Compliance Engineer EHS Warehousing & Facilities - Netherlands
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- Over 1500 employees work in the pharmaceutical, chemical and biotechnological production.
- Within company Biotech, novel biologic active ingredients (“Drug Substance”) are manufactured, including medicines for fertility, diabetes, and oncology.
- We have global partners in the U.S., Europe and Asia Pacific to ensure medicines are delivered in a safe, reliable and cost-effective way.
- The Supply Chain Management department consists of approximately 27 FTE.
- The Manufacturing Support Center is part of the Supply Chain Management department and the other supporting facilities of the Facilities & Engineering department
- Reporting into the Supply Chain Management Lead, the Compliance Engineer EHS will be responsible for ensuring compliance to internal and external EHS guidelines and regulations. You will be working closely together with the Manufacturing Support Center personnel, Facility & Engineering department, EHS Center of Excellence and external service providers.
- You will be responsible for maintaining and managing EHS processes within the Site and various Partners.
- You will also be responsible for leading improvement projects. Working as a Compliance Engineer, you will be responsible for:
- Ensuring a strong EHS compliance level of the facilities and service partners resulting in Permanent Inspection Readiness;
- Performing risk assessments; supporting line management & contract personnel by high risk work activities;
- Acting as SME during risk assessment like HAZOPs, FMEA, RIE and root cause analysis.
- Leading incident and near miss investigations, reporting in the Global EHS administrative systems, developing CAPAs where required and tracking actions until completion. Evaluating effectiveness of established CAPAs;
- Being consulted for changes in processes, equipment and investment projects (management of change);
- Ensuring compliance to work permit system (werkvergunningen system);
- Ensuring compliance to (Environmental) Permit;
- Maintaining and improving the processes and related procedures to comply to the latest EHS standards. This included writing & improving of various SOP’s and instructions;
- Ensuring that new regulations/ guidelines (EHS) are effectively communicated and trained to all relevant personnel. Support establishing annual EHS training plans;
- Coaching and teaching personnel on the shop-floor to obtain the right mindset and (improvement) culture;
- Monitoring of actual operational EHS compliance by Key Performance Indicators and initiating actions;
- Managing observations and/ or events and related communication. Developing corrective and preventive actions;
- Actively closing potential GAP’s with local or global guidelines by taking ownership of issues;
- Preparing and guiding internal and external inspections and audits;
- Solving potential observations from audits;
- Connecting to other EHS experts within the site or other company sites to harmonize & improve way of working.
- Maintaining or implementing a site-broad EHS standard.
- Bachelor’s or Master’s degree in Technology or EHS related discipline, with willingness to complete the appropriate EHS education (e.g. HVK Hogere Veiligheidskunde, IH (Industrial Hygiene);
- At least 3 years of EHS experience in highly regulated warehouse, commercial production or (industrial) service organization;
- Knowledge of GMP,ISPE, ISO and FDA;
- At least 3 years of relevant experience in a biotech, pharmaceutical, chemical manufacturing or food operations environment;
- Demonstrated ability to manage projects;
- Pro-active attitude with an improvement mindset and strong analytical skills;
- Ability to influence and communicate with all levels of the organization from shop floor to senior management;
- Leads by example and must have excellent communication skills with shop-floor personnel.
- Excellent communication skills in Dutch and English.
- Experience with PGS15, ADR regulation;
- Experience with Risk assessments, HAZOP’s;
- Experience with support of regulatory and corporate audits;
- Experience with Six Sigma and/ or Lean principles, yellow or green belt certification;
- Experience with contract management;
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